AML HAIRCHECK-DT (COCAINE)


Device Classification Name

enzyme immunoassay, cocaine and cocaine metabolites

510(k) Number K023626
Device Name AML HAIRCHECK-DT (COCAINE)
Original Applicant
QUEST DIAGNOSTICS, INC.
4230 burnham ave.
las vegas, 
NV 
89119 -5410

Original Contact patrick carpenter
Regulation Number 862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DIF   DLJ  
Date Received 10/29/2002
Decision Date 09/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No